Journal Article

Maximal Usage Trial of Tapinarof Cream 1% Once Daily in Pediatric Patients Down to 2 Years of Age with Extensive Atopic Dermatitis

Hebert, Adelaide A., Piscitelli, Stephen C., Paller, Amy S., Rubenstein, David S., Butners, Victoria, Fitzgerald, Nancy, Tabolt, Glenn, Gonzalez, Mercedes E.

2025

Overview

Tapinarof cream 1% is an aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration to treat atopic dermatitis (AD) in patients down to age 2 years. The aim of this study was to evaluate the safety and pharmacokinetics of tapinarof cream 1% once daily (QD) in adolescents and children with extensive AD under maximal usage conditions. Patients with a validated Investigator Global Assessment scale for Atopic Dermatitis™ (vIGA-AD™) score ≥ 3 and body surface area (BSA) involvement ≥ 25% (ages 12-17 years) or ≥ 35% (ages 2-11 years) were enrolled into three age cohorts (2-6, 7-11, and 12-17 years) and received tapinarof cream 1% QD for 4 weeks. Overall, 36 patients (12 per cohort) were enrolled; mean BSA affected was 42.8% (range 26.0-90.0) and mean Eczema Area and Severity Index (EASI) score was 23.8. At baseline, 28 patients (77.8%) had a vIGA-AD™ score of 3 (moderate). No-to-minimal tapinarof systemic exposure was observed (25% of post-treatment plasma samples were below the quantifiable limit of a highly sensitive assay [< 50 pg/mL]). Mean maximum plasma concentration (C ) was 2.44 ng/mL, and median time to C was 2.9 h. Eight patients (22.2%) reported treatment-emergent adverse events (TEAEs), which were mild or moderate; only one patient discontinued due to two unrelated TEAEs. One case of mild folliculitis and no contact dermatitis occurred. Tapinarof was well tolerated, including on sensitive skin and extensor/flexural surfaces. Tapinarof cream exhibits highly favorable safety and pharmacokinetics in adolescents and children down to age 2 years with extensive AD. ClinicalTrials.gov: NCT05186805.

• Publisher: Springer Nature B.V
• Subject: Administration, Cutaneous / Adolescent / Age / Age Factors / Body Surface Area / Caregivers / Child / Child, Preschool / Dermatitis / Dermatitis, Atopic - diagnosis / Dermatitis, Atopic - drug therapy / Drug Administration Schedule / Drug dosages / Enrollments / FDA approval / Female / Humans / Hydrocarbons / Male / Patients / Pharmacokinetics / Resorcinols - administration & dosage / Resorcinols - adverse effects / Resorcinols - pharmacokinetics / Severity of Illness Index / Skin / Skin Cream - administration & dosage / Skin Cream - adverse effects / Skin Cream - pharmacokinetics / Stilbenes / Teenagers / Treatment Outcome